The following data is part of a premarket notification filed by Shanghai Dasheng Health Products with the FDA for Ds N95 Surgical Masks And Flat Surgical.
| Device ID | K090131 |
| 510k Number | K090131 |
| Device Name: | DS N95 SURGICAL MASKS AND FLAT SURGICAL |
| Classification | Respirator, Surgical |
| Applicant | SHANGHAI DASHENG HEALTH PRODUCTS SONGJIANG DISTRICT Shanghai, CN |
| Contact | Maggie Zhong |
| Correspondent | Maggie Zhong SHANGHAI DASHENG HEALTH PRODUCTS SONGJIANG DISTRICT Shanghai, CN |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-21 |
| Decision Date | 2009-04-27 |
| Summary: | summary |